The following data is part of a premarket notification filed by Meridan Medical with the FDA for Fep Fixation System And Stylo Wrist Fixation System.
| Device ID | K032427 |
| 510k Number | K032427 |
| Device Name: | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM |
| Classification | Component, Traction, Invasive |
| Applicant | MERIDAN MEDICAL 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland MERIDAN MEDICAL 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-06 |
| Decision Date | 2003-10-09 |
| Summary: | summary |